US10478221B2 - Introducer for introduction of a prosthesis into a lumen of a patient - Google Patents
Introducer for introduction of a prosthesis into a lumen of a patient Download PDFInfo
- Publication number
- US10478221B2 US10478221B2 US15/626,295 US201715626295A US10478221B2 US 10478221 B2 US10478221 B2 US 10478221B2 US 201715626295 A US201715626295 A US 201715626295A US 10478221 B2 US10478221 B2 US 10478221B2
- Authority
- US
- United States
- Prior art keywords
- liquid absorbing
- introducer
- absorbing seal
- rotatable body
- distal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active, expires
Links
- 239000007788 liquid Substances 0.000 claims abstract description 61
- 239000012530 fluid Substances 0.000 claims abstract description 33
- 238000011010 flushing procedure Methods 0.000 claims abstract description 21
- 238000010521 absorption reaction Methods 0.000 claims abstract description 8
- 230000006835 compression Effects 0.000 claims description 37
- 238000007906 compression Methods 0.000 claims description 37
- 239000000017 hydrogel Substances 0.000 claims description 16
- 229920000642 polymer Polymers 0.000 claims description 8
- 239000004433 Thermoplastic polyurethane Substances 0.000 claims description 7
- 229920001971 elastomer Polymers 0.000 claims description 7
- 239000000806 elastomer Substances 0.000 claims description 7
- 229920002803 thermoplastic polyurethane Polymers 0.000 claims description 7
- 239000000463 material Substances 0.000 claims description 3
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- 210000000709 aorta Anatomy 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 230000017531 blood circulation Effects 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 230000003068 static effect Effects 0.000 description 2
- 239000011358 absorbing material Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 239000003431 cross linking reagent Substances 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 239000000416 hydrocolloid Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/3437—Cannulas with means for removing or absorbing fluid, e.g. wicks or absorbent pads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
- A61B2017/3464—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0062—Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Definitions
- the present disclosure relates generally to the field of medical devices. Particular embodiments are related to medical devices that are deployable into bodily lumens including vascular systems.
- a variety of medical devices have been developed for endovascular repair. For instance, various methods and devices have been developed to repair aneurysmal or occluded branches of the aorta. Many such devices include tubular introducers having internal passages, sometimes referred to as introducer catheters, that include a seal and/or valve to retard or stop blood flow through their internal passages. For instance, introducer catheters are known to employ CaptorTM valves. Introducers are typically designed to track along a guide wire and some introducers are designed to seal against both small diameter guide wires and larger diameter portions of delivery devices.
- distal with respect to a portion of the aorta, a deployment device or an endograft means the end of the aorta, deployment device or endograft further away in the direction of blood flow from the heart and the term “proximal” means the portion of the aorta deployment device or end of the endograft nearer to the heart in the direction of blood flow.
- proximal means the portion of the aorta deployment device or end of the endograft nearer to the heart in the direction of blood flow.
- an introduction of a prosthesis into a lumen of a patient comprising:
- a sheath having a proximal end and a distal end
- a housing mounted to the distal end of the sheath, the housing having a passage there-through adapted to receive a delivery assembly
- liquid absorbing seal for sealably receiving the delivery assembly, the liquid absorbing seal disposed within the housing distally of the port,
- liquid absorbing seal comprises hydrogel.
- the hydrogel comprises a lubricious polymer.
- the hydrogel is a hydrophilic thermoplastic polyurethane elastomer.
- the housing includes a cap, the cap retaining the liquid absorbing seal.
- the introducer further comprises a compression assembly, the compression assembly operable to compress the liquid absorbing seal.
- the compression assembly comprises an actuator and a compression segment.
- the actuator comprises a rotatable body, the rotatable body threadably connected to the housing, wherein the rotation of the rotatable body pushes the compression segment against the liquid absorbing seal thereby compressing the liquid absorbing seal.
- the compression segment is a separate component to the rotatable body and wherein the compression segment and the rotatable body are mutually arranged and constructed to allow relative rotation.
- the introducer further comprises a delivery assembly, the delivery assembly comprising:
- a tip mounted to a proximal end of the guide wire catheter
- a distal delivery member mounted around the guide wire catheter and located distal of the tip;
- the delivery assembly is slidably mounted through the introducer.
- liquid absorbing seal engages an external surface of the distal delivery member, wherein in a second condition the liquid absorbing seal engages an external surface of a guide wire,
- liquid absorbing seal comprises hydrogel.
- the hydrogel comprises a lubricious polymer.
- the hydrogel is a hydrophilic thermoplastic polyurethane elastomer.
- the housing includes a cap, the cap retaining the liquid absorbing seal.
- the introducer further comprises a compression assembly, the compression assembly operable to compress the liquid absorbing seal.
- the compression assembly comprises an actuator and a compression segment.
- the actuator comprises a rotatable body, the rotatable body threadably connected to the housing, wherein the rotation of the rotatable body pushes the compression segment against the liquid absorbing seal thereby compressing the liquid absorbing seal.
- the compression segment is a separate component to the rotatable body and wherein the compression segment and the rotatable body are mutually arranged and constructed to allow relative rotation.
- an introducer and a delivery assembly for introduction of a prosthesis into a lumen of a patient comprising:
- a sheath having a proximal end and a distal end
- a housing mounted to the distal end of the sheath, the housing having a passage there-through adapted to receive a delivery assembly
- liquid absorbing seal for sealably receiving the delivery assembly, the liquid absorbing seal comprising a hydrophilic thermoplastic polyurethane elastomer, the liquid absorbing seal disposed within the housing distally of the port,
- the delivery assembly comprising:
- FIG. 1 is a diagrammatic isometric view of a generalised introducer according to the invention
- FIG. 2 is a close up cross-sectional view of a first embodiment of an introducer according to the invention
- FIGS. 3A and 3B are similar views to that of FIG. 2 , but show parts of a delivery assembly inserted through the introducer;
- FIG. 4 is a close up cross-sectional view of a second embodiment of an introducer according to the invention.
- FIGS. 5A and 5B are similar views to that of FIG. 4 , but show parts of a delivery assembly inserted through the introducer;
- FIG. 6 is an isometric view of an introducer and a delivery assembly according to a third embodiment of the invention.
- an introducer 10 for introduction of a prosthesis, such as the prosthesis 5 shown in FIG. 6 , into a lumen of a patient is shown.
- the introducer 10 comprises a sheath 20 , most clearly shown in FIG. 1 , having a proximal end 22 and a distal end 28 .
- a housing 30 is mounted to the distal end 28 of the sheath 20 .
- the housing has a passage 35 therethrough as is most clearly shown in FIG. 2 .
- the passage 35 is adapted to receive a delivery assembly, such as the delivery assembly 100 shown in FIG. 6 .
- a port 34 is provided for introducing flushing fluid.
- the port 34 communicates with the passage 35 .
- the housing 30 shown in FIG. 2 is made from a plurality of parts, including a distal housing portion 38 . In other embodiments, more or less component parts may be used to form a suitable housing 30 .
- a liquid absorbing seal 50 can be seen in FIG. 2 .
- the liquid absorbing seal 50 for sealably receiving a delivery assembly, such as the delivery assembly 100 referred to above.
- the liquid absorbing seal 50 is disposed within the housing 30 distally of the port 34 . In use, introduction of a flushing fluid through the port 34 into the passage 35 results in absorption of a portion of the flushing fluid into the liquid absorbing seal, thereby swelling the liquid absorbing seal.
- the liquid absorbing seal 50 comprises a hydrogel. More specifically, the hydrogel comprises a lubricious polymer.
- a suitable lubricious polymer may include a hydrophilic thermoplastic polyurethane elastomer.
- suitable materials having the liquid-absorbing properties that result in expansion may include, but are not limited to the following: hydrocolloids that are polymer compositions of substantially water-insoluble, slightly cross-linked, partially neutralized polymers prepared from unsaturated polymerizable acid group-containing monomers and cross-linking agents; or any other suitable liquid absorbing materials known in the art.
- the housing 50 includes a fluid receiving chamber hole 55 which has a larger internal diameter than the external diameter of the pusher 110 . This allows flushing fluid entering the port 34 via a tube 33 to reach the liquid absorbing seal 50 . Once the liquid absorbing seal 50 has absorbed flushing fluid, it expands and becomes more lubricious. This results in the liquid absorbing seal 50 sealing effectively against the outer diameter of the pusher 110 , while at the same time allowing relative movement between the pusher 110 and the seal 50 .
- a cap 60 is provided to retain the liquid absorbing seal 50 , as illustrated in FIGS. 3A and 3B .
- the cap 60 snaps into place within the housing 30 .
- the cap 30 presents a holed disc shaped face to the liquid absorbing seal 50 as can be seen in FIG. 2 .
- Hole 54 through the holed disc shaped face allows access through the seal 50 to the fluid receiving chamber hole 55 .
- an introducer 10 further comprises a compression assembly 70 .
- the compression assembly 70 is operable to compress the liquid absorbing seal 50 .
- the compression assembly 70 comprises an actuator 71 and a compression segment 80 .
- the actuator 71 comprises a rotatable body.
- the rotatable body is threadably connected to the housing 30 . Rotation of the rotatable body pushes the compression segments 80 against the liquid absorbing seal 50 thereby compressing the liquid absorbing seal 50 .
- the compression segment 80 is a separate component to the rotatable body.
- the compression segment and the rotatable body are mutually arranged and constructed to allow relative rotation.
- the compression assembly 70 allows in the surgeon or another member of the surgical team to manually adjust the level of compression of the seal 50 .
- manual adjustment may be desirable when sealing over a fine guide wire such as the guide wire 7 illustrated in FIG. 6 .
- the compression assembly 70 may be of assistance.
- the delivery assembly 100 comprises a guide wire catheter 120 having a tip 130 mounted to a proximal end 122 thereof.
- a distal delivery member 110 which could be referred to as a pusher, is mounted around the guide wire catheter 120 and is located distal of the tip 130 .
- a prosthesis receiving portion 140 is provided between the tip 130 and the distal delivery member 110 .
- the delivery assembly 100 is slidably mounted through the introducer 10 .
- a handle 150 is manipulable to slide the distal delivery member (pusher) 110 through the introducer 10 .
- An introducer 10 together with a delivery assembly 100 , as illustrated in FIG. 6 read in conjunction with FIGS. 2, 3A and 3B , is provided packaged and ready for delivery to a hospital.
- the introducer 10 together with the delivery assembly 100 is unpackaged ready for use.
- a flushing fluid is then delivered via the tube 33 to the introducer 10 .
- the flushing fluid displaces air within the introducer 10 and the delivery device 100 .
- the flushing fluid is also able to reach the seal 50 through the passage 35 , the fluid receiving chamber 32 within the housing 30 and the fluid receiving chamber hole 55 .
- the flushing fluid travels through the fluid receiving chamber hole 55 and wets the seal 50 .
- the flushing fluid also pushes air out of the assembly through to the proximal end 22 of the introducer 10 .
- the seal 50 will tend to absorb some of the flushing fluid and will become more lubricious promoting a lower coefficient of friction.
- the introducer 10 can then be introduced to an artery of a patient for instance.
- the introducer may be inserted through an incision in the femoral artery using the Seldinger method.
- the surgeon may manipulate the handle 150 so as to slide the pusher 110 through the introducer 10 .
- the liquid absorbing seal 50 described above provides for a very low coefficient of friction between an outer surface of the pusher 110 and an inner surface of the seal 50 . This assists the surgeon in fine manipulations and generally facilitates use of the introducer 10 and the delivery assembly 100 .
- the seal 50 seals against the guide wire 7 , as illustrated in FIG. 3B .
- the ability of the seal 50 to seal against the relatively large diameter pusher 110 and against the relatively small diameter guide wire 7 is important to minimise blood loss.
- Blood in contact with the seal 50 contains fluid that is absorbable by the seal 50 . This ensures that the seal 50 remains in an expanded and lubricous state during an endovascular procedure.
- a further delivery device may be slid along the guide wire 7 so as to enter and pass through the introducer 10 .
- FIG. 3B shows a tip 130 of an introducer just before or after insertion.
Abstract
Description
-
- a guide wire catheter;
- a tip mounted to a proximal end of the guide wire catheter;
- a distal delivery member mounted around the guide wire catheter and located distal of the tip; and
- a prosthesis receiving portion between the tip and the distal delivery member
- wherein the delivery assembly is slidably mounted through the introducer, and
- wherein in a first condition the liquid absorbing seal engages an external surface of the distal delivery member, and
- wherein in a second condition the liquid absorbing seal engages an external surface of a guide wire,
- whereby in at least the second condition, absorption of fluid swells the liquid absorbing seal.
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP18275074.5A EP3417835A1 (en) | 2017-06-19 | 2018-05-31 | An introducer for introduction of a prosthesis into a lumen of a patient |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2017204135A AU2017204135B1 (en) | 2017-06-19 | 2017-06-19 | An introducer for introduction of a prosthesis into a lumen of a patient |
AU2017204135 | 2017-06-19 |
Publications (2)
Publication Number | Publication Date |
---|---|
US20180360491A1 US20180360491A1 (en) | 2018-12-20 |
US10478221B2 true US10478221B2 (en) | 2019-11-19 |
Family
ID=62748618
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/626,295 Active 2037-06-27 US10478221B2 (en) | 2017-06-19 | 2017-06-19 | Introducer for introduction of a prosthesis into a lumen of a patient |
Country Status (2)
Country | Link |
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US (1) | US10478221B2 (en) |
AU (1) | AU2017204135B1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023147422A2 (en) * | 2022-01-27 | 2023-08-03 | Medtronic, Inc. | Expandable introducer |
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US5104389A (en) * | 1991-06-27 | 1992-04-14 | Cordis Corporation | Medical instrument valve with foam partition member having vapor permeable skin |
US5250033A (en) | 1992-10-28 | 1993-10-05 | Interventional Thermodynamics, Inc. | Peel-away introducer sheath having proximal fitting |
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2017
- 2017-06-19 AU AU2017204135A patent/AU2017204135B1/en active Active
- 2017-06-19 US US15/626,295 patent/US10478221B2/en active Active
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Title |
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AU Application No. 2017204135 Examination Report No. 1, Cook Medical Technologies LLC, dated Jun. 19, 2017. |
AU Application No. 2017204135 Prior Art Disclosure Statement, Cook Medical Technologies LLC, dated Jun. 19, 2017. |
Examination Report No. 1 for Application No. AU2017204135, Cook Medical Technologies LLC, dated Jun. 19, 2017. |
Extended EU Search Report, Application No. 18275074.5, Cook Medical Technologies LLC, dated Oct. 22, 2018. |
Extended European Search Report, Application No. 18275074.5, Cook Medical Technologies LLC, dated Oct. 22, 2018. |
Prior Art Disclosure Statement for Application No. AU2017204135, Cook Medical Technologies LLC, dated Jun. 19, 2017. |
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US20180360491A1 (en) | 2018-12-20 |
AU2017204135B1 (en) | 2018-07-05 |
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